Quadra 4 Operator Manual
Tomtec
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paper forms of such documents will be considered as official and must accompany any
electronic records. Persons are expected to consult with the intended agency receiving
unit for details on how (e.g., method of transmission, media, file formats, and technical
protocols) and whether to proceed with the electronic submission.
Sec. 11.3 Definitions.
(a) The definitions and interpretations of terms contained in section 201 of the act apply
to those terms when used in this part.
(b) The following definitions of terms also apply to this part:
(1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 U.S.C.
321-393)).
(2) Agency means the Food and Drug Administration.
(3) Biometrics means a method of verifying an individual's identity based on
measurement of the individual's physical feature(s) or repeatable action(s) where those
features and/or actions are both unique to that individual and measurable.
(4) Closed system means an environment in which system access is controlled by
persons who are responsible for the content of electronic records that are on the
system.
(5) Digital signature means an electronic signature based upon cryptographic methods
of originator authentication, computed by using a set of rules and a set of parameters
such that the identity of the signer and the integrity of the data can be verified.
(6) Electronic record means any combination of text, graphics, data, audio, pictorial, or
other information representation in digital form that is created, modified, maintained,
archived, retrieved, or distributed by a computer system.
(7) Electronic signature means a computer data compilation of any symbol or series of
symbols executed, adopted, or authorized by an individual to be the legally binding
equivalent of the individual's handwritten signature.
(8) Handwritten signature means the scripted name or legal mark of an individual
handwritten by that individual and executed or adopted with the present intention to
authenticate a writing in a permanent form. The act of signing with a writing or marking
instrument such as a pen or stylus is preserved. The scripted name or legal mark, while
conventionally applied to paper, may also be applied to other devices that capture the
name or mark.
(9) Open system means an environment in which system access is not controlled by
persons who are responsible for the content of electronic records that are on the
system.
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